Zylet vs TobraDex in Blepharokeratoconjunctivitis

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00447577

First Posted: March 14, 2007

Last Update Posted: December 9, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Bausch & Lomb Incorporated

Purpose

The objective of this study is to evaluate the safety and efficacy of Zylet vs. Tobradex in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis

Condition	Intervention	Phase
Blepharokeratoconjunctivitis	Drug: Loteprednol etabonate and tobramycin ophthalmic suspension Drug: Tobramycin and dexamethasone ophthalmic suspension	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Participant) Primary Purpose: Treatment
Official Title:	A Clinical Safety and Efficacy Evaluation of Zylet (Loteprednol Etabonate and Tobramycin Ophthalmic Suspension) vs. Tobradex (Tobramycin and Dexamethasone Ophthalmic Suspension) in the Treatment of Blepharokeratoconjunctivitis

Resource links provided by NLM:

Drug Information available for: Dexamethasone Tobramycin Tobramycin sulfate Loteprednol etabonate

U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:

The primary efficacy endpoint for this study is the change from baseline to Day 15 in the signs and symptoms composite score [ Time Frame: 15 days ]

Secondary Outcome Measures:

The distribution of Investigator global assessment at each visit. [ Time Frame: Visit 2, 3 & 4 ]
The percentage of eyes that were considered improved or cured at each visit based on the Investigator global assessment. [ Time Frame: Visit 2, 3 & 4 ]
The change from baseline to Day 7 (Visit 3) and to Day 3 (Visit 2) in the signs and symptoms composite score. [ Time Frame: Visit 2 & 3 ]
The change from baseline to each visit in the signs composite score and the symptoms composite score. [ Time Frame: Visit 1, 2, 3 & 4 ]
The change from baseline to each visit in the Blepharitis signs composite score, the conjunctivitis signs composite score, and the Keratitis signs composite score. [ Time Frame: Visit 1, 2, 3 & 4 ]
The change from baseline to each visit in individual signs and symptoms. [ Time Frame: Visit 1, 2, 3 & 4 ]
VA, Biomicroscopy, and IOP assessments at each visit [ Time Frame: Visit 1, 2, 3 & 4 ]
Adverse Events [ Time Frame: Visit 1, 2, 3 & 4 ]


Enrollment:	276
Study Start Date:	January 2007
Study Completion Date:	June 2007
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Zylet Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5%/0.3% (Zylet)	Drug: Loteprednol etabonate and tobramycin ophthalmic suspension Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.
Active Comparator: Tobradex Tobradex (tobramycin and dexamethasone ophthalmic suspension, 0.3%/0.1%), US marketed product (Alcon) from commercial lots.	Drug: Tobramycin and dexamethasone ophthalmic suspension Subjects will self-administer the study drug in the affected eye(s) 4 times a day (QID) for 14 days.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must be at least 18 years of age
Must be able and willing to comply with all treatment and follow up procedures
Must have the ability to understand and sign an Informed Consent Form and provide Health Insurance Portability and Accountability Act (HIPAA) authorization
Must be able to self-administer drugs
Must have a clinical diagnosis of blepharokeratoconjunctivitis in at least one eye (total Ocular Signs and Symptoms score of at least 10, with at least one ocular sign and one ocular symptom each having a score of Grade 2 level or higher)
Women of childbearing potential must be sexually inactive or using an approved birth control methods and must have a negative urine pregnancy test
Must be willing to discontinue contact lens use for the duration of the study
Must have pin-holed Snellen visual acuity equal to or better than 20/40 in both eyes

Exclusion Criteria:

Any uncontrolled systemic disease or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis)
Known hypersensitivity to the study drugs or their components (including benzalkonium chloride) or contraindications to tobramycin or ocular corticosteroids
Use of any systemic or topical ophthalmic non-steroidal anti-inflammatory agents, analgesics, and antihistamines that cannot be discontinued during the study
Use of any topical ophthalmic medications, including tear substitutes, within 2 hours before and that cannot be discontinued during the study
Use of any systemic or topical ophthalmic antibiotic agents within 72 hours before and that cannot be discontinued during the study
Use of any systemic or topical ophthalmic corticosteroid agents within 7 days before and that cannot be discontinued during the study
Use of any systemic or topical ophthalmic mast cell stabilizers within 14 days before and that cannot be discontinued during the study
Use of any topical ophthalmic immunosuppressant (e.g. Restasis) agents within 30 days before and that cannot be discontinued during the study
Suspected preseptal cellulites, or any other disease conditions which the Investigator determines could interfere with the safety and efficacy evaluations of the study drug
Suspected dacrocystitis
Participation in an ophthalmic drug or device research study within the 30 days prior to entry in this study
Ocular surgery (including laser surgery) in either eye within the past 3 months

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00447577

Locations


United States, North Carolina
Cornerstone Eye Care
High Point, North Carolina, United States, 27262

Sponsors and Collaborators

Bausch & Lomb Incorporated

Investigators


Study Director:	Timothy Comstock, OD	Bausch & Lomb Incorporated

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

White EM, Macy JI, Bateman KM, Comstock TL. Comparison of the safety and efficacy of loteprednol 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of blepharokeratoconjunctivitis. Curr Med Res Opin. 2008 Jan;24(1):287-96.


Responsible Party:	Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:	NCT00447577 History of Changes
Other Study ID Numbers:	512
First Submitted:	March 12, 2007
First Posted:	March 14, 2007
Last Update Posted:	December 9, 2011
Last Verified:	December 2011

Additional relevant MeSH terms:


Dexamethasone acetate Dexamethasone BB 1101 Tobramycin Loteprednol Etabonate Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents	Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Bacterial Agents Anti-Infective Agents Anti-Allergic Agents

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